How to Register a New Drug in the USA

Overview

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes how to register a drug through the new drug application (NDA) process administered by the Center for Drug Evaluation and Research (CDER). The course outlines submission requirements and document preparation steps. It concludes with an in-depth analysis of the NDA review process and sponsors’ opportunity for interaction with the US Food and Drug Administration (FDA).

Featured Topics

NDA process under the CDER

NDA review process and the FDA

Who Should Attend

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields